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OpenTrials
Completed

NCT Number: NCT00806923

A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bahía Blanca, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients, >=18 years of age;
  • documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
  • adequate liver and kidney function;
  • women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.

Exclusion criteria

  • prior chemotherapy or treatment with another systemic cancer therapy;
  • surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
  • brain metastasis or spinal cord compression;
  • fertile men, and women of childbearing potential, not using adequate contraception;
  • treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.

Treatment and study plan

Cisplatin

Drug

80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles

Gemcitabine

Drug

1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles

Placebo

Drug

iv on day 1 of each 3 week cycle until disease progression

bevacizumab [Avastin]

Drug

15mg/kg 1v on day 1 of each 3 week cycle until disease progression

Primary outcomes

  1. Progression-free survival

    Time frame: Event driven

Secondary outcomes

  1. Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.

    Time frame: Event driven

  2. Safety:AEs, laboratory tests, SAEs, coagulation parameters

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Dec 11, 2008
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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